Quality Management of Personalized Implants: Impact of New Regulations

By Axel Dubois and Julien Deckx



Personalized implants have become a key part of the offering for orthopaedic, dental, and cranio-maxillofacial surgery, with proven outcomes. However, because of the specific regulatory situation of such implants, the quality of such products varies widely depending on the manufacturer. Additionally, the regulatory situation has evolved drastically in recent times.  

In this webinar, Axel Dubois, CEO at SLS France, elaborates on the efforts and challenges related to the proper validation of the full workflow to design and manufacture personalized implants. 


In this recording, you will learn :

  • What steps go into the process to create and validate qualitative personalized implants  
  • How recent regulatory changes affect this effort 
  • What to ask to manufacturers about the safety and quality of their personalized products
  • What the advantages are of using certified software for designing personalized implants 



Materialise medical device software may not be available in all markets because product availability is subject to the regulatory and/ or medical practices in individual markets. In countries where no regulatory registration is obtained of Mimics and/or 3-matic Medical, a research version is available. Please contact your Materialise representative if you have questions about the availability of Materialise medical device software in your area.


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